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510(k) K070264

50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB by Terumo Europe N.V. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
January 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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